Recall Z-2357-2023
Ortho-Clinical Diagnostics · initiated June 5, 2023
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
VITROS Immunodiagnostic Products Troponin I ES Reagent Pack
Codes / lots: Product Code: 6802301; UDI-DI: 10758750002504; Lot No.: 4800; Expiration Date: 10-Jun-2023.
Reason for recall
Reagent packs could potentially contain incorrect wells, which will generate incorrect, and potentially false negative, results.
FDA-determined cause: Process control
Action taken
Customers were sent a recall notification by mail dated 06/05/2023. The notification that customers immediately discontinue use of affected devices and discard any remaining inventory. Any discarded product will be replaced by QuidelOrtho or credit will be provided. Customers are asked to return the provided Confirmation of Receipt Form no later than 06/12/2023. If affected devices were further distributed customers are asked to forward the provided notification to those downstream customers. This notice is to be posted by all VITROS Systems until the expiration of affected devices, which is 06/10/2023. Customers with any questions may contact Quidel Ortho at 1-800-421-3311.
Details
- Recall number
- Z-2357-2023
- Initiated
- June 5, 2023
- Posted by FDA
- August 8, 2023
- Product code
- MMI – Immunoassay Method, Troponin Subunit
- Quantity
- 4,013 units
- Distribution
- Worldwide distribution - US Nationwide and the country of Canada.
- Recalling firm
- Ortho-Clinical Diagnostics, Bridgend
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2358-2023 Class II | VITROS Immunodiagnostic Products Troponin I ES CalibratorsReagent packs could potentially contain incorrect wells, which will generate incorrect, and potentially… | 06/05/2023Open, Classified |